ING. ASEGURANZA CALIDAD 3

Ing. Aseguranza Calidad

At Fresenius Medical Care, we are the global leader in kidney care, committed to improving the lives of patients with chronic kidney disease. Our mission is to deliver high-quality, innovative products, services, and care across the entire healthcare journey. Guided by our vision “Creating a future worth living. For patients. Worldwide. Every day.” we work with purpose and compassion, supported by a global team of over 110,000 employees.
Within our Care Enablement segment, we develop and provide life-sustaining medical products, digital health solutions, and therapies that empower clinical teams and improve patient outcomes. Our FME Reignite strategy drives transformation through innovation, efficiency, and sustainable growth.
Our values guide how we work:
•    We Care for our patients, each other, and our communities
•    We Connect across teams and borders to deliver excellence together
•    We Commit to doing things the right way growing with purpose and leading kidney care with integrity and innovation
Information about plant: mandatory!

At our Tijuana plant in Mexico, we are dedicated to delivering high-quality dialysis medical products that support patient care around the world. The facility specializes in the manufacturing and servicing of cyclers and cartridges used in both chronic and acute dialysis treatments. It also plays a key role in molding & extrusion and dialysate production. With a committed team of approximately 2400 employees, we continue to drive innovation and contribute to improved outcomes in dialysis care globally. Join our passionate team and be part of this global impact!

Summary about role:
Ensures compliance with product/process specifications by evaluating procedures and analyzing data in accordance with Quality System requirements and applicable regulations.

Your Responsibilities:

• Monitors, collects, and analyzes customer complaints by product family.
• Monitors, collects, and analyzes defects and rejections found during the process by product family.
• Investigates and documents quality system metrics and continuous improvement initiatives.
• Controls and manages Temporary Deviations (TD) that impact the business unit or product family.
• Monitors, controls, and ensures the proper disposition of nonconforming material.
• Implements procedures, methodologies, and quality tools to meet product and process specifications.
• Analyzes and leads investigations of product and process failures, including those related to suppliers, validating the effectiveness of corrective actions.
• Supports validation processes and applicable protocols in collaboration with the Engineering department, and is also responsible for generating test method validations.
• Develops and follows up on guidelines for product and component test methods.
• Ensures analytical and/or statistical information is generated for the area, collaborating with Engineering to establish, control, and improve process effectiveness.
• Supports required quality activities to ensure the Quality System remains active and up to date.

Your Profile:

Our Offer For You:

There is a lot you can discover at Fresenius Medical Care, regardless in which field you are an expert and how much experience you have -  all dedicated to your professional journey.

•    Whether in front of or behind the scenes - you are helping to make ever better medicine available to more and more people around the world
•    Individual opportunities for self-determined career planning and professional development
•    A corporate culture in which there is enough room for innovative thinking - to find the best solution together, not the quickest one
•    A large number of committed people with a wide range of skills, talents and experience
•    The benefits of a successful global corporation with the collegial culture of a medium-sized company